Mabthera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An infusion Centre Based Approach (Mabthera DUS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC02) rituximab

  rituximab

Population studied

• Short description of the study population:
  Nononcology MabThera patients in the UK, Germany, France, Italy, and Spain during a 10-month period concomitantly with the medical record abstraction process.
• Age groups:
  Adults (18 to < 46 years)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  1. To quantify and characterise off-label use through an evaluation of the disease andcharacteristics of patients treated with MabThera for non-oncology conditions.2. To evaluate the extent to which patients receive and read the PAC, knowledge of the PAC content among patients receiving MabThera for non-oncology conditions
• Data analysis plan:
  Analysis of MabThera off-label use and evaluation of PAC knowledge and utilisation will be descriptive in nature and will entail the tabular display of summary statistics and thefrequency distribution of item responses. A detailed analysis plan describing methods of analysis and presentation, as well as table shells, will be developed prior to starting analysis of data. All analyses will be performed using SAS 9.2 (or higher) statistical software (SASInstitute Inc. Cary, North Carolina, USA).